Clinical Research Assistant at Cliantha Research (2023-02 – Present)
Clinical Research Assistant in a contract clinical research organization (CRO) environment, responsible for clinical trial management, execution, and coordination across multiple early and late-phase trials.
- Frequently served as a lead and co-lead in various early and late-phase clinical trials within a contract clinical research organization (CRO) environment.
- As a clinical trial study lead, responsible for initiating the study and reviewing the protocol, feasibility review, sponsor and investigator meetings, IRB communication, document creation, screening and outpatient visits, close-out activities, and audit meetings.
- Took charge as a study lead, managing a pilot study and then following it with a main study after changing some aspects of the protocol with the approval of the IRB, the sponsor, management, and the principal investigator.
- Proficient in managing different clinical trial designs and skillfully solving study-specific problems.
- Experienced in presenting findings to management concerning issues with the clinical trial execution or participant inquiries.
- Coordinate different visits, record adverse events, and conduct the informed consent process.
- Lead research teams throughout the study, and collaborate with other departments to ensure accurate data collection.
- Manage the flow of daily trial procedures at the clinic.
- Work closely with a team of site personnel and quality assurance monitors to perform accurate and ethical trials.
- Ensure documents are always audit-ready and in compliance with SOP.
- As a co-lead, performed different audits for trials across different areas of clinical research.
- Comfortable communicating with the different departments and taking responsibility for team's work.
- Document and monitor adverse events (AEs/SAEs) to present an urgent report.
- Create new standard operating procedures (SOPs) based on reducing GDP and GCP errors by staff.
- Review the eCRF for uniformity and completeness.
- Extensive knowledge of research regulations, such as ICH-GCP guidelines, the Helsinki Declaration, the FDA, and Health Canada guidelines.
- Obtain vital signs measurements, lung function tests, allergy skin prick tests, participant dosing (oral and nasal), investigational product applications, participant interviews, and dosing site assessments.
- Managed and supported more than 15 clinical trials as part of a collaborative team, with great success, allowing me to take on more crucial responsibilities.
- Track clinical trial deviations and maintain a comprehensive database.
- Create and maintain adverse event databases.
- Perform accurate clinical data entry for numerous studies, on different data collection software (Code/Angelo, Medidata), with an emphasis on information consistency.
- Maintain communication as a liaison between the different departments, while providing updates to management on the progress of the study.
- Experienced in handling trial-sensitive documents and organizing tasks based on urgency.
Senior Anatomy Lab Assistant at Brock University (2022-09 – 2023-05)
Senior Anatomy Lab Assistant responsible for coordinating with volunteers, professors, and teaching staff to facilitate effective collaboration and academic research.
- Connected frontline volunteers with professors, course coordinators, and teaching assistants, ensuring effective collaboration.
- Facilitated weekly meetings to address any concerns and provide guidance.
- Participated in organizing the yearly anatomy symposium at Brock University.
- Demonstrated exceptional organizational skills in coordinating multiple tasks.
- Academic research experience in producing Monthly reports based on completed milestones.
Frontline Anatomy Lab Assistant at Brock University (2021-09 – 2022-05)
Frontline Anatomy Lab Assistant responsible for teaching students detailed anatomy and organizing exam review sessions.
- Took charge of an anatomy lab station and actively taught students about detailed anatomy, including the musculature of the human body.
- Created and provided a study guide with effective anatomy study methods.
- Conducted and planned three anatomy exam review sessions for students.
- Responsible for grading students on two assessments per semester.
